Headache After Diagnostic Lumbar Puncture (HELPUmeå)
Primary Purpose
Post-Lumbar Puncture Headache
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sprotte 25G needle, stylet reinserted
Sprotte 25G needle, stylet not reinserted
Sprotte 22G needle, stylet reinserted
Sprotte 22G needle, stylet not reinserted
Spinocan 25G needle, stylet reinserted
Spinocan 25G needle, stylet not reinserted
Sponsored by
About this trial
This is an interventional prevention trial for Post-Lumbar Puncture Headache focused on measuring Lumbar puncture, Headache
Eligibility Criteria
Inclusion Criteria:
- Subjects undergoing diagnostic LP during their neurological work-up at Umeå University Hospital, Sweden, from 28 May 2013 until the study is fully recruited and;
- Willing to participate and
- Providing informed consent
Exclusion Criteria:
-Subjects unable to participate in the study follow-up
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Sprotte 25G needle, stylet reinserted
Sprotte 25G needle, stylet not reinserted
Sprotte 22G needle, stylet reinserted
Sprotte 22G needle, stylet not reinserted
Spinocan 25G needle, stylet reinserted
Spinocan 25G needle, stylet not reinserted
Arm Description
Outcomes
Primary Outcome Measures
Odds ratio for post-lumbar puncture headache (any)
Any post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).
Secondary Outcome Measures
Odds ratio for post-lumbar puncture headache (severe)
Severe (preventing daily activities) post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).
Headache duration (days)
Proportion using analgesia
Proportion on sick leave
Proportion with back pain
Proportion with radiating leg pain
Multiplicative interactions between age (years), sex, BMI and needle visavi the outcome "any post-LP headache" in a multivariable logistic regression model
Interactions between important predictors of headache and needle allocation, assessed in multivariable logistic regression models with interaction terms which are the products of the two potentially interacting variables. Age and BMI will be treated as continuous variables, sex and needle allocation as categorical variables.
Full Information
NCT ID
NCT03960749
First Posted
May 2, 2019
Last Updated
May 20, 2019
Sponsor
Jonatan Salzer
Collaborators
Umeå University
1. Study Identification
Unique Protocol Identification Number
NCT03960749
Brief Title
Headache After Diagnostic Lumbar Puncture
Acronym
HELPUmeå
Official Title
The Importance of Needle Size, Needle Design and Stylet Reinsertion to Prevent Post-lumbar Puncture Headache, a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 28, 2013 (Actual)
Primary Completion Date
June 24, 2018 (Actual)
Study Completion Date
October 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jonatan Salzer
Collaborators
Umeå University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objectives of this study are to investigate the effects of needle design, needle size and stylet reinsertion on the risk for headache after diagnostic LP (lumbar puncture, Post-LP headache). The following needles are used in the study:
Sprotte 25 Gauge (G) (0.5 mm) atraumatic needle with introducer
Sprotte 22 G (0.7 mm) atraumatic needle with introducer
Spinocan 25 G (0.5 mm) cutting needle
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Lumbar Puncture Headache
Keywords
Lumbar puncture, Headache
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, parallel group. Randomization between three different lumbar puncture needles and between stylet reinsertion of not before needle withdrawal.
Masking
ParticipantOutcomes Assessor
Masking Description
The participants are not informed about the allocated needle. The follow-up telephone calls (outcome assessment) are made by an assistant nurse who is unaware of randomization allocation.
Allocation
Randomized
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sprotte 25G needle, stylet reinserted
Arm Type
Experimental
Arm Title
Sprotte 25G needle, stylet not reinserted
Arm Type
Experimental
Arm Title
Sprotte 22G needle, stylet reinserted
Arm Type
Experimental
Arm Title
Sprotte 22G needle, stylet not reinserted
Arm Type
Experimental
Arm Title
Spinocan 25G needle, stylet reinserted
Arm Type
Experimental
Arm Title
Spinocan 25G needle, stylet not reinserted
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Sprotte 25G needle, stylet reinserted
Intervention Description
Lumbar puncture with small bore atraumatic needle, stylet reinserted before needle withdrawal
Intervention Type
Device
Intervention Name(s)
Sprotte 25G needle, stylet not reinserted
Intervention Description
Lumbar puncture with small bore atraumatic needle, stylet not reinserted before needle withdrawal
Intervention Type
Device
Intervention Name(s)
Sprotte 22G needle, stylet reinserted
Intervention Description
Lumbar puncture with larger bore atraumatic needle, stylet reinserted before needle withdrawal
Intervention Type
Device
Intervention Name(s)
Sprotte 22G needle, stylet not reinserted
Intervention Description
Lumbar puncture with larger bore atraumatic needle, stylet not reinserted before needle withdrawal
Intervention Type
Device
Intervention Name(s)
Spinocan 25G needle, stylet reinserted
Intervention Description
Lumbar puncture with small bore cutting needle, stylet reinserted before needle withdrawal
Intervention Type
Device
Intervention Name(s)
Spinocan 25G needle, stylet not reinserted
Intervention Description
Lumbar puncture with small bore cutting needle, stylet not reinserted before needle withdrawal
Primary Outcome Measure Information:
Title
Odds ratio for post-lumbar puncture headache (any)
Description
Any post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).
Time Frame
Up to 14 days after LP
Secondary Outcome Measure Information:
Title
Odds ratio for post-lumbar puncture headache (severe)
Description
Severe (preventing daily activities) post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).
Time Frame
Up to 14 days after LP
Title
Headache duration (days)
Time Frame
Until cessation, up to 14 days after LP
Title
Proportion using analgesia
Time Frame
During post-lumbar puncture headache, up to 14 days after LP
Title
Proportion on sick leave
Time Frame
During post-lumbar puncture headache, up to 14 days after LP
Title
Proportion with back pain
Time Frame
Up to 14 days after LP
Title
Proportion with radiating leg pain
Time Frame
Up to 14 days after LP
Title
Multiplicative interactions between age (years), sex, BMI and needle visavi the outcome "any post-LP headache" in a multivariable logistic regression model
Description
Interactions between important predictors of headache and needle allocation, assessed in multivariable logistic regression models with interaction terms which are the products of the two potentially interacting variables. Age and BMI will be treated as continuous variables, sex and needle allocation as categorical variables.
Time Frame
Up to 14 days after LP
Other Pre-specified Outcome Measures:
Title
Procedure duration (minutes)
Description
Procedure duration from start of procedure (defined as when the operator starts palpating the iliac crest) until procedure cessation (defined as when the needle is withdrawn from the participant).
Time Frame
During the lumbar puncture
Title
Proportion undergoing needle switch
Description
Technical difficulties may differ between needles and thus the proportion undergoing needle switch due to these difficulties may differ.
Time Frame
During the lumbar puncture
Title
Opening pressure (cm H2O)
Description
Opening pressure measured immediately after cerebrospinal fluid (CSF) contact using a thin tube attached to a paper ruler, using the skin entry hole as reference point. This is only performed in the recumbent position.
Time Frame
During the lumbar puncture
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects undergoing diagnostic LP during their neurological work-up at Umeå University Hospital, Sweden, from 28 May 2013 until the study is fully recruited and;
Willing to participate and
Providing informed consent
Exclusion Criteria:
-Subjects unable to participate in the study follow-up
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11061243
Citation
Evans RW, Armon C, Frohman EM, Goodin DS. Assessment: prevention of post-lumbar puncture headaches: report of the therapeutics and technology assessment subcommittee of the american academy of neurology. Neurology. 2000 Oct 10;55(7):909-14. doi: 10.1212/wnl.55.7.909. No abstract available.
Results Reference
background
PubMed Identifier
19009898
Citation
Hyllienmark L, Zachau AC. [Diagnostic lumbal puncture]. Lakartidningen. 2008 Oct 8-14;105(41):2844-9. No abstract available. Swedish.
Results Reference
background
PubMed Identifier
16116106
Citation
Armon C, Evans RW; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Addendum to assessment: Prevention of post-lumbar puncture headaches: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2005 Aug 23;65(4):510-2. doi: 10.1212/01.wnl.0000173034.96211.1b.
Results Reference
background
PubMed Identifier
9102578
Citation
Strupp M, Brandt T. Should one reinsert the stylet during lumbar puncture? N Engl J Med. 1997 Apr 17;336(16):1190. doi: 10.1056/NEJM199704173361616. No abstract available.
Results Reference
background
PubMed Identifier
21549395
Citation
Hammond ER, Wang Z, Bhulani N, McArthur JC, Levy M. Needle type and the risk of post-lumbar puncture headache in the outpatient neurology clinic. J Neurol Sci. 2011 Jul 15;306(1-2):24-8. doi: 10.1016/j.jns.2011.04.004. Epub 2011 May 5.
Results Reference
background
PubMed Identifier
11756618
Citation
Strupp M, Schueler O, Straube A, Von Stuckrad-Barre S, Brandt T. "Atraumatic" Sprotte needle reduces the incidence of post-lumbar puncture headaches. Neurology. 2001 Dec 26;57(12):2310-2. doi: 10.1212/wnl.57.12.2310.
Results Reference
background
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Headache After Diagnostic Lumbar Puncture
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